美国FDA就召回法规征求意见 　　

 

　　按照美国FDA的要求，产品召回企业需要及时将召回事项通知相关的FDA辖区办公室。企业需提供召回原因、风险评估、生产数量、销售信息、产品召回策略、联系方式等详细信息，还需要将召回事项通知直接客户，并提供给客户一套报告方案。

 

　　美国FDA还要求企业提供周期性状态报告，以便及时掌握召回进展情况。

 

　　部分原文报道如下：

 

　　The Food and Drug Administration （FDA or Agency） is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 （PRA）， Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.

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